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RECRUITING
NCT06252649
PHASE3

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Official title: Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-07-17

Completion Date

2032-04-25

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

FOLFIRI Regimen

Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

DRUG

Sotorasib

Immediate-release solid dosage form administered orally.

DRUG

Panitumumab

Administered via IV infusion Q2W.

DRUG

Bevacizumab-awwb

Administered via IV infusion Q2W.

Locations (291)

Ironwood Cancer and Research Centers Scottsdale

Chandler, Arizona, United States

Providence Saint Jude Medical Center

Fullerton, California, United States

City of Hope National Medical Center

Long Beach, California, United States

Cancer and Blood Research Center, LLC

Los Alamitos, California, United States

California Research Institute

Los Angeles, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, United States

D and H Cancer Research Center

Margate, Florida, United States

Mid Florida Hematology and Oncology Centers PA

Orange City, Florida, United States

Boca Raton Clinical Research Medical Center Inc

Plantation, Florida, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Insight Research Institute

Chicago, Illinois, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Henry Ford Health System

Detroit, Michigan, United States

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Saint Louis Cancer Care West County

Bridgeton, Missouri, United States

Minniti Center for Medical Oncology and Hematology

Mickleton, New Jersey, United States

Duke Cancer Center

Durham, North Carolina, United States

FirstHealth Cancer Center

Pinehurst, North Carolina, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Carolina Blood and Cancer Care

Rock Hill, South Carolina, United States

Tennessee Oncology PLLC - Chattanooga

Nashville, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Hospital Universitario Fundacion Favaloro

CABA, Buenos Aires, Argentina

Instituto Argentino de Diagnóstico y Tratamiento

CABA, Buenos Aires, Argentina

Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL

CABA, Buenos Aires, Argentina

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Británico de Rosario

La Plata, Buenos Aires, Argentina

Instituto de Investigaciones clinicas de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

Sanatorio Allende

Córdoba, Córdoba Province, Argentina

Clinica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Exelsus Oncologia Clinica

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Centro Oncologico Riojano Integral

La Rioja, Argentina

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Austin Health, Austin Hospital

Heidelberg, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

Landeskrankenhaus Feldkirch

Rankweil, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria

Krankenhaus Wiener Neustadt

Wiener Neustadt, Austria

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Institut Jules Bordet

Brussels, Belgium

Grand Hôpital de Charleroi - Site des Viviers

Charleroi, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Algemeen Ziekenhuis Sint Maarten-Emmaus vzw

Mechelen, Belgium

AZ Delta Campus Rumbeke

Roeselare, Belgium

Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, Belgium

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Hospital Sirio Libanes Brasilia

Brasília, Federal District, Brazil

Vencer e Oncoclinica

Teresina, Piauí, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Fundacao pio xII Barretos

Barretos, São Paulo, Brazil

Oncoclinicas Belo Horizonte

Barretos, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Fundacao Antonio Prudente AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto Cancer Sao Paulo Icesp

São Paulo, Brazil

Instituto Brasileiro de Controle do Cancer Ibcc

São Paulo, Brazil

Oncologia Rede D Or

São Paulo, Brazil

Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

Haskovo, Bulgaria

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, Bulgaria

Complex Oncology Center Plovdiv EOOD

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment Serdikamed EOOD

Sofia, Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Bulgaria

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, Canada

Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

James Lind Centro de Investigacion del Cancer

Temuco, Cautín, Chile

Centro de investigacion y desarrollo oncolgico Spa

Temuco, Cautín, Chile

Enroll SpA

Providencia, Santiago Metropolitan, Chile

Clinica Redsalud Vitacura, Instituto del Cancer

Vitacura, Santiago Metropolitan, Chile

Fundacion Arturo Lopez Perez

Santiago, Chile

Centro de Oncologia de Precision (Medicina de Precision Celerity)

Santiago, Chile

Biocinetic servicios medicos limitada

Santiago, Chile

Clinical Research Chile SpA

Valdivia, Chile

Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales

Medellín, Antioquia, Colombia

Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

Rionegro, Antioquia, Colombia

Instituto Nacional de Cancerologia

Bogota, Cundinamarca, Colombia

Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic

Bogotá, Cundinamarca, Colombia

Instituto Medico de Alta Tecnologia sas - Imat sas

Montería, Departamento de Córdoba, Colombia

Fundacion Oftalmologica de Santander - Foscal

Floridablanca, Santander Department, Colombia

Masarykuv onkologicky ustav

Brno, Czechia

And 191 more locations on ClinicalTrials.gov